WOMEN�S CANCER SCREENING PROGRAM

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					                                      Cancer Screening / Follow-up
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CLINICAL PROTOCOLS

Minimal Requirements for a Cancer Screening Visit Matrix ......................................................... 1

Breast Cancer Screening ............................................................................................................ 2
          Risk Factors............................................................................................................... 2
          Screening History ...................................................................................................... 2
          Clinical Breast Examination & Mammography ........................................................... 2
          Patient Education on Breast Health ........................................................................... 3

Cervical Cancer Screening.......................................................................................................... 4
           Risk Factors............................................................................................................... 4
           Screening History ...................................................................................................... 4
           Screening Guidelines................................................................................................. 5
           Age-Delineated Cervical Cancer Screening Schedule ............................................... 6


CASE MANAGEMENT

Breast Cancer Follow-up ............................................................................................................. 7
          Surgical Referrals ...................................................................................................... 7
          Follow-up ................................................................................................................... 7
          Treatment .................................................................................................................. 7
          Bi-Rads Classification of Mammogram Results & Management................................. 9
          Algorithm for Breast Cancer Screening Follow-up.................................................... 10

Cervical Cancer Follow-up ........................................................................................................ 11
           Bethesda 2001 System ............................................................................................ 11
           Patient Education on Cervical Health ....................................................................... 11
           Follow-up ................................................................................................................. 12
           Abnormal Pap Test Referral & Management............................................................ 15
           Treatment ................................................................................................................ 13
           Follow-up Pap Test After Colposcopy Evaluation or treatment ................................ 17

Diagnostic Services & Approved CPT Codes ............................................................................ 18

Tracking & Follow-up Requirements ......................................................................................... 22
                               MINIMAL REQUIREMENTS FOR A
                                 CANCER SCREENING VISIT
                           ASSESSMENT                                                INITIAL VISIT       ANNUAL VISIT
Comprehensive Health History to include:
  Family history of breast/genital/colon-rectal cancers                              Required                Required
  LMP or date of menopause                                                      (Health History and      (Interval Health
  Contraceptive method if childbearing age                                           Physical          History and Physical
  Documentation of HRT or ERT if menopausal                                     Examination Form)          Examination
  Date of last Pap/mammogram and results                                                                      Form)
  Previous abnormal Pap, diagnostics, treatments
  Previous breast problems, diagnostics, treatments
  Assessment for breast/cervical cancer risk factors
Physical Examination to include:
  Documentation of general appearance and mental status
  Height/Weight/BMI
  Blood pressure
  Clinical breast examination (Using MammaCare® Technique)                             Required             Required
  Pelvic examination that includes visualization of the vulva,
   vagina, cervix/vaginal cuff and thorough bimanual including
   adnexae
  Rectal exam (age 50 and as indicated for others)
  Other as needed
Laboratory: Pap test (as indicated by age guidelines)                                   Required             Required
  Fecal occult blood testing (ages 50 and older)
       o 3 kits given with instructions                                                 Required             Required
       o If positive, refer to M.D.
  Hemoglobin                                                                          If indicated         If indicated

  STD testing                                                                        If indicated by      If indicated by
                                                                                       history/exam         history/exam
Referral for annual mammogram (age > 40)                                                  Required             Required
Counseling: (Documentation in medical record required)
 - ACH-40 (“Improving Health for Women”) – CSEM
given/counseled and patient verbalized understanding
   Monthly BSE/Annual CBE
   Pap/Mammogram rescreening recommendations
   Regular exercise
   Adequate diet (low fat, high fiber, 5 fruits/vegetables daily)
   Osteoporosis/prevention and bone density testing                                    Required             Required
   Risks/Benefits of HRT if menopausal
   Contraception if needed
   Smoking risks/cessation and referral
   Immunization needs/update
   STD risk counseling if indicated
   Ovarian Cancer Screening at age 50 (age 25 if family history)
    (Locations: UKMC; Hardin, Mason, Floyd, McCracken, and
    Pulaski County Health Centers) call 1-800-766-8279 for appt.
Documentation of Return Clinic Appointments                                             Required             Required
Follow-up of Abnormal Test Results                                                      Required             Required




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                                                  Core Clinical Service Guide
                                             Section: Cancer Screening / Follow-up
                                                       September 1, 2012
                          BREAST CANCER SCREENING
Early diagnosis of breast cancer offers women more treatment options and greatly reduces
mortality. Early diagnosis is aided by the triad of monthly breast self-exam, annual clinical
breast exam and, if age appropriate, regular mammography screening.

A. BREAST CANCER RISK FACTORS:
   1. Female age 40 or older
   2. First degree relative (mother, sister, daughter) with history of breast cancer before the
      age of 50 (pre-menopausal)
   3. Personal history of a benign breast condition
   4. Early menarche (prior to age 12)
   5. Late menopause (after age 52)
   6. No pregnancies or first pregnancy after age 30
   7. Obesity and a high fat diet may also contribute to the development of breast cancer

B. BREAST SCREENING HISTORY:
   1. Include dates and results of previous mammograms
   2. Elicit personal history of breast symptoms including pain, tenderness, nipple discharge,
      palpable mass or skin changes
   3. Document any personal history of breast cancer and previous biopsies or treatments
   4. Screen for risk factors (listed above)

C. CLINICAL BREAST EXAMINATION AND MAMMOGRAPHY
   1. All females should be taught monthly SBE beginning at age 20. Counseling shall be
      documented in the medical record at the initial and annual visits.
   2. A clinical breast exam is recommended annually on all females beginning at age 20.
   3. The required method for performing the clinical breast exam and teaching SBE is the
      MammaCare Method® using the principles of positioning, three levels of palpation, and
      recommended search patterns.
   4. Routine screening mammograms will begin at age 40 and are recommended on an annual
      basis. In menstruating women, the mammogram should be scheduled about 2 weeks after
      the LMP.
   5. Women age 30 and older with an abnormal clinical breast examination should be
      referred for a diagnostic mammogram. If the woman is under the age of 30, an
      ultrasound is usually preferred as a substitution for the mammogram due to the typically
      dense breast tissue hindering interpretation of the test; however the radiologist may
      choose to do a diagnostic mammogram in this age group if appropriate.
   6. Women with a family history (mother, sister or daughter) of pre-menopausal breast cancer
      (before the age of 50) and with a NORMAL CBE should begin yearly screening
      mammograms 10 years earlier than family member’s breast cancer diagnosis (no younger
      than age 25). If patient is unable to remember 1st degree family member’s age, begin
      screening mammogram at age 35.
   7. Women that have been diagnosed with either of 4 lesions; atypical hyperplasia, radial
      scar, papillomatosis, or lobular cancer in situ by biopsy, will need to begin annual
      screening mammograms.


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                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
   8. Women with breast implants should be scheduled for an annual screening mammogram
      beginning at age 40 unless clinical complaint (i.e., pain in breast).
   9. Women that have had chest wall radiation will need to begin annual screening
      mammograms 10 years after radiation completed (no younger than age 25).
  10. Women post mastectomy will need annual diagnostic mammogram of the opposite
      breast.

D. PATIENT EDUCATION ON BREAST HEALTH
   1. Counseling with documentation at the initial and annual visits shall include teaching BSE
      using the MammaCare method, individual breast cancer risk factors and the importance
      of annual CBE with regular mammogram screenings if age appropriate.
   2. Patients with either an abnormal CBE or mammogram result will have documented
      counseling done as appropriate.




                       CERVICAL CANCER SCREENING
Routine periodic screening encourages early identification of precancerous conditions of the
cervix and early stage diagnosis of cervical cancer. Most cervical cancer can be PREVENTED
with detection and early treatment of precancerous lesions.

A. CERVICAL CANCER RISK FACTORS
   1. History of HPV and/or Dysplasia
   2. Multiple (3 or more) sexual partners in lifetime
   3. A sex partner with multiple sex partners
   4. A sex partner who has had a partner with HPV/dysplasia/cervical cancer
   5. Cigarette smoking (any amount)
   6. Beginning sexual intercourse at a young age (age 18 or less)
   7. History of 2 or more sexually transmitted infections
   8. Intrauterine exposure to diethylstilbestrol (DES)
   9. Infrequent screening (>5 years since last Pap)
  10. Immunosuppressed (HIV/AIDS, diabetes, transplant recipient, chronic steroid use, auto-
      immune disorders)
B. CERVICAL SCREENING HISTORY
   1. Elicit date and result of last Pap test
   2. Determine if a previous history of an abnormal Pap and/or HPV
   3. Determine if history of a previous colposcopy & biopsy and/or treatment
   4. Screen for risk factors (listed above)
   5. Screen for history of abnormal bleeding patterns




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                                       Core Clinical Service Guide
                                  Section: Cancer Screening / Follow-up
                                            September 1, 2012
                                        Pelvic Examination
The purpose of this section is to outline components of a pelvic exam, when to start screening,
and how often to continue screening.
The pelvic examination serves multiple purposes, including the assessment of the vulva, vagina,
cervix, uterus and adnexa. The pelvic examination includes:
     inspection of the external genitalia, urethra and introitus;
     examination of the vagina and cervix; and
     bimanual examination of the uterus, cervix, adnexa and ovaries.
If indicated, rectovaginal examination is performed as a part of the examination. Some health
care providers incorporate the rectovaginal examination as part of the routine examination.
Annual pelvic examination is a routine part of the preventive care for all women 21 years
of age and older even if they do not need a Pap smear. A bimanual pelvic examination is
generally not necessary at the initial reproductive health visit. A general physical examination,
including an external genital examination, may be done because it allows assessment of
secondary sexual development, reassurance and education. A “teaching” external-only genital
examination can provide an opportunity to familiarize adolescents with normal anatomy, assess
adequacy of hygiene and allow the health care provider an opportunity to visualize the perineum
for any anomalies. Pelvic examination need only be performed in adolescents when it is likely to
yield important information regarding conditions such as amenorrhea, abnormal bleeding,
vaginitis, presence of a possible foreign body, pelvic pain, pelvic mass or a sexually transmitted
disease (STD). If the patient has had sexual intercourse, screening for STDs is important. Refer
to STD Guidelines.

Refer any abnormal finding on the pelvic examination to a mid level or higher clinician or a
contracted gynecologist for further evaluation.
Adapted from ACOG Committee Opinion, Number 431, May 2009.

C. CERVICAL CANCER SCREENING GUIDELINES
   1. Women ages 21- 29 years old without a history of cervical cancer, or in utero exposure to
      DES and who are not immunocompromised should have cytology screening every 3
      years. Pap tests should begin at 21 years of age (may be done earlier at clinician’s
      discretion based on abnormal clinical findings). If the patient is a minor with a potentially
      life-threatening test result (includes “Adenocarcinoma-In-Situ”, “HSIL” or “ASC-H”
      result) and cannot be contacted, the parent or guardian may be contacted (KRS
      214.185(6)). Minors shall be made aware of this policy at the screening visit.

   2. Women ages 30-65 without a history of CIN2+, cervical cancer, or in utero exposure to
      DES and who are not immunocompromised have two options for cervical cancer
      screening. One recommendation for screening is cytology every three years. Another
      option for women in this age group, who want to lengthen the screening interval, is
      screening with a combination of cytology and HPV testing every 5 years. “Women
      choosing co-testing to increase their screening interval should be aware that positive
      screening results are more likely with HPV-based strategies than with cytology alone and
      that some women may require prolonged surveillance with additional frequent testing if
      they have persistently positive HPV results. The percentage of U.S. women undergoing
      co-testing who will have a normal cytology test result and a positive HPV test result (and
      who therefore require additional testing) ranges from 11% among women age 30 to 34
      years to 2.6% among women age 60 to 65 years.”

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                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
3. Women older than 65 with documentation of adequate negative prior screening, who are
   not otherwise at high risk for cervical cancer and have no history of CIN2+ within the last
   20 years should not be screened. Adequate negative prior screening is three consecutive
   negative cytology results or two consecutive negative co-tests within the 10 years before
   cessation of screening, with the most recent test occurring within the past 5 years.

4. Women who have received the HPV vaccine should continue to be screened according to
   the age-appropriate guidelines.

5. Perform Pap test before Genprobe specimens, wet mounts, or pelvic examination.

6. Reschedule Pap test if patient is on her menses with heavy bleeding.

7. May use small amount K-Y jelly on the outer surface of the speculum for patient comfort.
   The entire portio of the cervix must be visualized to obtain an adequate specimen.

8. The sample from the portio should be taken first followed by the endocervical sample.

9. Place collected material immediately in the liquid fixative container if doing a liquid-
   based Pap such as ThinPrep. If using the conventional method, the collected material
   should be applied uniformly to the slide without clumping and rapidly fixed to avoid air-
   drying which results in artifact and unsatisfactory specimens.

10. For DES exposed patients, a smear from the upper two thirds of the vagina should be
    obtained in addition to the cervix on an annual basis.

11. In those patients who are post hysterectomy:
        a. With a cervical stump – continue cervical Pap tests as recommended.
        b. Without a cervical stump:
               1. Cessation of Screening: Women who have had a hysterectomy with
                   removal of the cervix for benign reasons (benign gyn disease such as
                   fibroids) and with no history of abnormal or cancerous cell growth may
                   discontinue routine cytology testing (Pap tests). Women with a total
                   hysterectomy still need to have annual vulvar/vaginal exam, CBE, and
                   mammogram visits. If there are abnormal findings on
                   vulvar/vaginal/labial exam or a past history of CIN2+ , refer the patient to
                   a qualified medical provider to evaluate for appropriate follow-up.
                   Vaginal/Vulvar/Labial Pap tests or biopsies should be referred to be
                   performed by a qualified medical provider and for evaluation for
                   appropriate follow-up.Vulvar/vaginal/labial follow-up is not reimbursed
                   by the KWCSP and payment would be the patient’s responsibility. Please,
                   refer to STD program guidance for information on follow-up and/or
                   treatment for positive STD findings. Note: For abnormal findings on CBE
                   and mammogram please see the preceding section on Breast Cancer
                   Screening and Follow-Up.

               2. Exceptions of cessation: Women with the following conditions should be
                  screened annually regardless of their age: immunosuppression (i.e., renal
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                                     Core Clinical Service Guide
                                Section: Cancer Screening / Follow-up
                                          September 1, 2012
                 transplant, etc.), HIV infection, DES exposure in utero or unknown Pap
                 test screening history. Patients with a history of cervical cancer or
                 treatment for CIN 2 or CIN 3 need annual screening for the next 20 years.
                 Vaginal/Vulvar/Labial Pap tests or biopsies should be referred to be
                 performed by a qualified medical provider and for evaluation for
                 appropriate follow-up. Vulvar/vaginal/labial follow-up is not reimbursed
                 by the KWCSP and payment would be the patient’s responsibility.


12. Always complete the laboratory form in its entirety including LMP, contraceptive
    method, HRT/ERT and previous abnormal Pap tests or diagnostic/treatment procedures.




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                                   Core Clinical Service Guide
                              Section: Cancer Screening / Follow-up
                                        September 1, 2012
Age – Delineated Cervical Cancer Screening Schedule
Age – Delineated Cervical Cancer Screening Schedule
        Ages < 21                            No Screening

                                                                                                                                      Annual screening
                                           Screen every 3 yr (annually                                                                or per guidelines in
      Ages 21-29                            if immunosuppressed or                                             YES                    cases of CIN 2/3
                                                  HIV-positive)
                                                Hx of CIN2/3 see Note
                                                                                                                                      HPV and                     Screen
                                                                                                                                      cytology                   every 5 yr
      Ages 30-65                            History of CIN2/3, HIV-positive,
                                                                                                                                      negative
                                            immunosuppressed, history of
                                                     DES exposure
                                                                                                               NO
                                                                                                                                      Cytology                    Repeat every
                                           Discontinue screening IF:
                                                                                                                                      negative                        3 yr
                                           (1) adequate negative prior screening*
                                           (2) No CIN2 within 20 years
        Ages > 65                          (3) no exposure to DES in utero
                                           (4) No history of cervical cancer
                                           (5) Not immunosuppressed

*Adequate negative prior screening is three consecutive negative cytology results or two consecutive negative co-tests within the 10 years before cessation of screening, with
the most recent test occurring within the past 5 years.

Note: If a patient is diagnosed with CIN2 or CIN3 under the 2009 ACOG guidelines, screen these patients annually until age 21. Refer them to the appropriate
provider if their Pap results are ASC-H, HSIL or greater. Once this patient reaches age 21, then begin her Pap smear screening using the updated guidelines.
Her previous abnormal pathology results (i.e., CIN2 or CIN3) would not be considered in this algorithm if diagnosed before age 21. (She should not be followed
annually for 20 years secondary to a CIN2 or CIN3 diagnosed before age 21.)




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                                                                                   Core Clinical Service Guide
                                                                              Section: Cancer Screening / Follow-up
                                                                                        September 1, 2012
                         BREAST CANCER FOLLOW-UP
A. SURGICAL REFERRALS
     1. Women with an abnormal CBE must be referred for surgical consultation regardless of
        diagnostic mammogram or ultrasound results unless CBE is done by radiologist and
        found to be negative/benign. Thorough documentation by the radiologist shall be
        required.
     2. Any patient with a bloody nipple discharge (unilateral or bilateral) requires a referral
        to a surgeon for evaluation.
     3. Any patient with a spontaneous (without nipple stimulation) and/or unilateral nipple
        discharge requires a referral to a surgeon for evaluation.
     4. Bilateral non-bloody discharge that occurs only with nipple stimulation does not need
        referral to a surgeon. This type of nipple discharge may be due to fibrocystic changes
        (usually greenish), hormonal imbalance, pregnancy, lactation and some medications
        (oral contraceptives, phenothiazides, anti-hypertensives, tranquilizers). If the clinician
        (MD or ARNP) determines the need for further evaluation of this type of nipple
        discharge, it typically is to either a gynecologist or endocrinologist.
     5. If a patient presents with a “breast lump” that she has discovered on BSE but both the
        CBE and mammogram (or ultrasound) are normal, she may be referred to a surgeon
        for a second opinion.

B. FOLLOW-UP
   1. Patients with an abnormal mammogram or ultrasound result shall be notified by the
      health department within 10 working days of receiving the result or within 30 days of the
      procedure, whichever comes first.
   2. Referrals for a surgical consult, requested additional mammography views or request for
      a breast ultrasound must be made within 3 weeks (21 days) of abnormal CBE or receipt
      of abnormal mammogram.
   3. A final diagnosis must be made within 60 days of the abnormal CBE or abnormal
      mammogram result (from date screened).
   4. Copies of results from consults & diagnostic procedures (including pathology reports)
      will be received and placed in the medical record within 60 days of the consult or
      diagnostic procedure.
   5. The month and year the next mammogram is due will be documented on the CH3A.

C. TREATMENT
  Patients that have been screened/diagnosed through KWCSP may be eligible for the treatment
  fund if diagnosed with pre-cancer/cancer of breast. For more information and forms related to
  BCCTP, please refer to their website at http://chfs.ky.gov/dms/bcctp.

  To be eligible for Medicaid, an applicant or recipient shall be a citizen of the United States as
  verified through documented evidence presented during initial application as required in 907
  KAR 1:011. The LHD shall verify patient’s identity and citizenship by viewing the patient’s
  driver license and birth certificate. For patients who were born in Kentucky and do not have a
  copy of their birth certificate or for more information about the citizenship documentation
  requirement, contact the Department for Medicaid Services at 502-564-6204. Other patients
  will need to contact Vital Statistics in their state of birth in order to obtain an original birth
  certificate. A passport may also be used for documentation of both identity and citizenship.
                                                 Page 8 of 27
                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
  Complete the Pre-screening Eligibility Form using the Medicaid Web application. Then,
  complete application and call Medicaid for confirmation number. The original signed
  application, Pre-screening Eligibility Form and proof of identity and citizenship should be
  maintained in the patient’s chart in the administrative section.

  As stated on the Department for Medicaid Services BCCTP website, some patients may
  require longer than the standard period of treatment and may be granted a Medicaid eligibility
  extension. An eligibility extension form (MAP - 813D Breast and Cervical Cancer Treatment
  Program Extension) can be obtained from the department's Web site or by calling toll-free
  (866) 818-0073.

  During the initial BCCTP application process, the NCM shall inform the patient to contact
  the NCM two weeks prior to the end of her Medicaid eligibility period if her treatment
  plan will extend past that eligibility period. Extension requests must be initiated by the
  treating physician. The NCM will assist the physician in obtaining an extension form to
  complete on the patient’s behalf. When extension request review is completed, recipients
  will receive a notice of their new eligibility status. The link for information related to the
  BCCTP is http://chfs.ky.gov/dms/bcctp/.

  TREATMENT PROGRAM ELIGIBILITY INFORMATION

      A Pap test, mammogram, ultrasound or MRI does not provide a definitive diagnosis of
       pre-cancer or cancer. These are considered screening tests. Note: The KWCSP does not
       reimburse for an MRI.
      A patient must have a biopsy that confirms either a diagnosis of cancer or pre-cancer of
       the cervix or breast for her to be eligible for the BCCTP.
      Cancer or pre-cancer of the vagina, vulva, labia or uterine/endometrial lining do not make
       a patient eligible for the BCCTP. The BCCTP is for cancer or pre-cancer treatment of
       the breast or cervix for women diagnosed through the KWCSP.
      A biopsy result of CIN II Moderate Dysplasia or greater on a biopsy of the cervix is
       required for a patient to be considered eligible clinically for the BCCTP.
      Once the biopsy diagnosis is confirmed, the NCM will begin the process of ensuring that
       an application is completed for the patient to be enrolled with Medicaid (BCCTP).
      The NCM is responsible for initiating the BCCTP application when a final diagnosis has
       been received and patient eligibility determined. Support staff at the LHD may assist or
       perform the application process.

Below, are some conditions that are considered pre-cancerous conditions when found on a
biopsy. If the patient receives one of these diagnoses or a diagnosis of cancer, she is eligible for
the BCCTP.
Breast Pre-cancerous Conditions
        Lobular carcinoma-in-situ
        Atypical hyperplasia
        Benign Phylloides tumors
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                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
          Some types of papillomatosis
          Radial scar sometimes referred to as sclerosing lesions


D. BI-RADS CLASSIFICATION OF MAMMOGRAM RESULTS AND MANAGEMENT
   Category 0: Assessment Incomplete
               This category indicates the need for additional imaging, which will be
               recommended by the radiologist or old films required for comparison.
   Category 1: Negative
               Recommendation should be made for routine follow-up according to the
               screening guidelines. Notify the patient when it is time for re-screening.
               (Refer to surgeon if CBE is abnormal)
   Category 2: Benign Finding
               Recommendation should be made for routine follow-up according to the
               screening guidelines. Notify the patient when it is time for re-screening.
               (Refer to surgeon if CBE is abnormal)
   Category 3: Probably Benign
               Follow-up should be provided according to the radiologist’s recommendation.
               Usually the radiologist will recommend a repeat mammogram in six months.
               Counsel the patient on the results of the mammogram and provide a re-screening
               appointment. (Refer to surgeon if CBE is abnormal)
   Category 4: Suspicious Abnormality
               A biopsy should be considered. Refer to a surgeon for further evaluation.
               Counsel the patient on the results of the mammogram and assure that
               arrangements are made for the surgical consultation.
   Category 5: Highly Suggestive of Malignancy
               There is probability of cancer. Refer to a surgeon for further evaluation.
               Counsel the patient on the results of the mammogram and assure that the
               arrangements are made for the surgical consultation.
   Category 6: Known Biopsy-Proven Malignancy-Appropriate Action Should Be Taken
               This category is reserved for lesions identified on the imaging study with biopsy
               proof of malignancy prior to definitive therapy.




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                                        Core Clinical Service Guide
                                   Section: Cancer Screening / Follow-up
                                             September 1, 2012
          ALGORITHM FOR BREAST CANCER SCREENING FOLLOW-UP

                               ANNUAL CLINICAL BREAST EXAMINATION




   NORMAL & BENIGN FINDINGS ON CBE                                                     ABNORMAL CBE
(Includes fibrocystic changes & normal nodularity)                           (Discrete mass or abnormal thickening)




 1. REPEAT CBE IN ONE YEAR                                      1. BREAST ULTRASOUND (ages 29 and under)

 2. ANNUAL SCREENING MAMMOGRAM IF                               2. DIAGNOSTIC MAMMOGRAM (ages 30 & older)
    AGE 40 AND OLDER                                               and ultrasound if needed

 3. IF SCREENING MAMMOGRAM IS                                   3.    SURGICAL REFERRAL APPOINTMENT WITHIN 3
    ABNORMAL, PATIENT TO BE NOTIFIED                                  WEEKS OF DISCOVERY OF ABNORMAL CBE
    WITHIN 10 DAYS OF RECEIVING THE                                   (Regardless of ultrasound and/or mammogram results)
    RESULT OR WITHIN 30 DAYS OF THE
    PROCEDURE (whichever comes first)                           4.    FINAL DIAGNOSIS OBTAINED WITHIN 60 DAYS
                                                                      OF DETECTION OF ABNORMALITY (from date
 4. A FINAL DIAGNOSIS OBTAINED WITHIN                                 screened)
    60 DAYS OF DETECTION OF THE
    ABNORMALITY (from date screened)                            5.    RECORDS TO BE RECEIVED WITHIN 60 DAYS OF
                                                                      CONSULT/PROCEDURES
 5. OBTAIN SCREENING MAMMOGRAM
    WRITTEN REPORT WITHIN 60 DAYS OF                            6.    FOLLOW RECOMMENDATIONS OF SURGEON
    THE PROCEDURE                                                     AND/OR RADIOLOGIST




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                                                   Core Clinical Service Guide
                                              Section: Cancer Screening / Follow-up
                                                        September 1, 2012
                       CERVICAL CANCER FOLLOW-UP
A. THE BETHESDA 2001 SYSTEM
   The Bethesda System for reporting cervical and/or vaginal cytology is the recognized system
   for reporting results. The LHD is required to contract with a laboratory that uses this system
   of reporting. The state computerized reporting options for Pap test findings, and the protocols
   for management of abnormal findings are based on the Bethesda 2001 System.

    SPECIMEN ADEQUACY
      Satisfactory
      Unsatisfactory

   GENERAL CATEGORIZATION
     Negative for Intraepithelial Lesion or Malignancy (NIL)
     Epithelial Cell Abnormality

   NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY

   NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY WITH:
     Presence of Organisms
            Trichomoniasis
            Candida
            Shift in vaginal flora suggestive of bacterial vaginosis
            Bacterial morphology consistent with Actinomyces
            Cellular changes consistent with Herpes simplex virus
     Reactive cellular changes
            Inflammation
            Radiation effects
            IUD effects
            Metaplasia (normal)
            Atrophy

   EPITHELIAL CELL ABNORMALITIES PRESENT
      Squamous Cell Abnormality
      Atypical Squamous Cells of Undetermined Significance (ASC-US)
      Atypical Squamous Cells cannot exclude a High-Grade Lesion (ASC-H)
      Low Grade Squamous Intraepithelial Lesion (CIN I, Mild Dysplasia, HPV) (LSIL)
      High Grade Squamous Intraepithelial Lesion (CIN II, CIN III, Moderate Dysplasia,
      Severe Dysplasia, Carcinoma-In-Situ/CIS) (HSIL)
      Squamous Cell Carcinoma

   GLANDULAR CELL ABNORMALITY (AGC)
     Atypical endocervical, glandular or endometrial cells
     Adenocarcinoma-In-Situ or Adenocarcinoma

B. PATIENT EDUCATION ON CERVICAL HEALTH
   1. Counseling on cervical cancer risk factors and risk reduction (including smoking
      cessation) during screening visits is required.
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                                   Section: Cancer Screening / Follow-up
                                             September 1, 2012
   2. If Pap test results reveal HPV or dysplasia, the patient is to be counseled on HPV and
      smoking (as a co-factor in developing cervical cancer). Also counsel on the increased
      exposure risks with multiple partners. These patients must have documented counseling
      as appropriate.

C. FOLLOW-UP
   1. Patients with abnormal Pap test shall be notified within 10 working days from the date
      the Pap test is received at the clinic.
   2. Referral appointments must be made within 3 weeks (21 days) of the clinic receiving the
      abnormal Pap test result. Any delay in meeting this timeframe must be documented in
      the patient’s medical record, including any “1st available” appointment
   3. A final diagnosis must be made within 60 days of the Pap test screening. The final
      diagnosis is based on colposcopy and biopsy results.
   4. Results of referrals including colposcopy, biopsy path reports, cryotherapy, LEEP
      procedure and pathology reports, CKC procedure and pathology reports and Laser
      treatment documentation must be received within 60 days of the procedure.
   5. The month and year the next Pap test is due is to be documented on the progress note.

D. ABNORMAL PAP TEST REFERRAL AND MANAGEMENT
   1. Local health departments will provide (either onsite or by offsite provider) for diagnostic
      evaluation of the following Pap results:
           a. High Grade Squamous Intraepithelial Neoplasia (CIN II, CIN III, CIS).
           b. Atypical Glandular (Includes atypical endocervical and atypical endometrial)
               Cells of Undetermined Significance (AGC)
           c. Squamous Cell Carcinoma or Carcinoma-In-Situ
           d. Adenocarcinoma-In-Situ or Invasive Adenocarcinoma
           e. Low Grade Intraepithelial Neoplasia (CIN I, Condyloma) (LSIL)
           f. ASC-H (Atypical Squamous Cells: Cannot Exclude High-Grade SIL)
           g. Atypical Squamous Cells of Undetermined Significance (ASC-US)
   2. All colposcopy providers are expected to have at least an 85% correlation between the
      Pap and biopsy result.
   3. The contracted provider should review the cytology, colposcopy and histology results
      when no lesion or only biopsy-confirmed CIN 1 is identified after coloposcopy in women
      with HSIL Pap test results. If the review yields a revised interpretation, management
      should follow American Society for Colposcopy and Cervical Pathology (ASCCP)
      guidelines for the revised interpretation; if a cytological interpretation of HSIL is upheld
      or if review is not possible, a diagnostic excisional procedure (e.g., LEEP) is preferred in
      non-pregnant patients.
   4. Benign glandular cells in a post hysterectomy female is normal and does not require
      further evaluation unless the cells are “atypical glandular”.
   5. If a negative (for intraepithelial lesion or malignancy) Pap test is received without
      endocervical cells or lacking a transformation zone (TZ), repeat the Pap within 6 months
      if: a) the patient has a prior Pap result of ASC-US or greater without 3 negative follow-
      up Pap test results (at least one of which contained an EC/TZ component) b) a previous
      Pap with unexplained glandular abnormality c) a positive high-risk/oncongenic human
      papillomavirus (HPV) test within 12 months d) clinician inability to clearly visualize the
      cervix or sample the endocervical canal e) immunosuppression f) insufficient previous
      screening (not participating in at least routine screening). Otherwise, repeat at next
      annual pelvic examination.
                                               Page 13 of 27
                                        Core Clinical Service Guide
                                   Section: Cancer Screening / Follow-up
                                             September 1, 2012
   6. Refer patient if abnormal cervix or polyps visualized.
   7. A result of “endometrial cells in a woman past age 40” requires a consult with the
      contracted provider if she is having abnormal bleeding or is post menopausal and not
      using hormone replacement therapy; otherwise repeat Pap test at next regular visit.

E. TREATMENT
  Patients that have been screened/diagnosed through KWCSP may be eligible for the treatment
  fund if diagnosed with pre-cancer/cancer of cervix (includes endocervical). For more
  information and forms related to BCCTP, please refer to their website at
  http://chfs.ky.gov/dms/bcctp.

  To be eligible for Medicaid, an applicant or recipient shall be a citizen of the United States as
  verified through documented evidence presented during initial application as required in 907
  KAR 1:011. The LHD shall verify patient’s identity and citizenship by viewing the patient’s
  driver license and birth certificate. For patients who were born in Kentucky and do not have a
  copy of their birth certificate or for more information about the citizenship documentation
  requirement, contact the Department for Medicaid Services at 502-564-6204. Other patients
  will need to contact Vital Statistics in their state of birth in order to obtain an original birth
  certificate. A passport may also be used for documentation of both identity and citizenship.

  Complete the Pre-screening Eligibility Form using the Medicaid Web application. Then,
  complete application and call Medicaid for confirmation number. The original signed
  application, Pre-screening Eligibility Form and proof of identity and citizenship should be
  maintained in the patient’s chart in the administrative section.

  As stated on the Department for Medicaid Services BCCTP website, some patients may
  require longer than the standard period of treatment and may be granted a Medicaid eligibility
  extension. An eligibility extension form (MAP - 813D Breast and Cervical Cancer Treatment
  Program Extension) can be obtained from the department's Web site or by calling toll-free
  (866) 818-0073.

  During the initial BCCTP application process, the NCM shall inform the patient to contact
  the NCM two weeks prior to the end of her Medicaid eligibility period if her treatment
  plan will extend past that eligibility period. Extension requests must be initiated by the
  treating physician. The NCM will assist the physician in obtaining an extension form to
  complete on the patient’s behalf.
  When extension request review is completed, recipients will receive a notice of their new
  eligibility status. The link for information related to the BCCTP is
  http://chfs.ky.gov/dms/bcctp/.

  TREATMENT PROGRAM ELIGIBILITY INFORMATION

      A Pap test, mammogram, ultrasound or MRI does not provide a definitive diagnosis of
       pre-cancer or cancer. These are considered screening tests. Note: The KWCSP does not
       reimburse for an MRI.
      A patient must have a biopsy that confirms either a diagnosis of cancer or pre-cancer of
       the cervix or breast for her to be eligible for the BCCTP.
                                                Page 14 of 27
                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
      Cancer or pre-cancer of the vagina, vulva, labia or uterine/endometrial lining do not make
       a patient eligible for the BCCTP. The BCCTP is for cancer or pre-cancer treatment of
       the breast or cervix for women diagnosed through the KWCSP.
      A biopsy result of CIN II Moderate Dysplasia or greater on a biopsy of the cervix is
       required for a patient to be considered eligible clinically for the BCCTP.
      Once the biopsy diagnosis is confirmed, the NCM will begin the process of ensuring that
       an application is completed for the patient to be enrolled with Medicaid (BCCTP).
      The NCM is responsible for initiating the BCCTP application when a final diagnosis has
       been received and patient eligibility determined. Support staff at the LHD may assist or
       perform the application process.

Below, are some conditions that are considered pre-cancerous conditions when found on a
biopsy. If the patient receives one of these diagnoses or a diagnosis of cancer, she is eligible for
the BCCTP.
Cervical Pre-cancerous Conditions
        High grade squamous epithelial lesions (CIN II Moderate Dysplasia, CIN lll Severe
            Dysplasia/ Carcinoma in Situ)
        Adenocarcinoma-in-Situ


LOOP ELECTRICAL EXCISION PROCEDURE (LEEP), Diagnostic vs Treatment
A local surgical procedure known as a LEEP or a cone biopsy can be considered either a
diagnostic or treatment procedure.
A patient’s colposcopy biopsy may be benign, show mild dysplasia or a biopsy may not be
performed. However, a physician may determine that it is necessary to perform a LEEP to
obtain a more comprehensive or accurate specimen. When a patient’s colposcopy biopsy is
benign, mild or a biopsy was not performed, a LEEP would be considered a diagnostic procedure
and would be covered under the KWCSP.
When a LEEP procedure is performed on a patient who had a colposcopy diagnosis of CIN ll
Moderate Dysplasia or greater, the LEEP would be considered treatment and should be covered
under the BCCTP. The NCM should ensure that the patient begins the application process for
the BCCTP after receiving the colposcopy diagnosis.




                                                Page 15 of 27
                                         Core Clinical Service Guide
                                    Section: Cancer Screening / Follow-up
                                              September 1, 2012
         MANAGEMENT OF ABNORMAL PAP TEST RESULTS
                           (Numbers correspond to PSRS submission)

#1 SATISFACTORY / NEGATIVE FOR INTRAEPITHELIAL LESION
    For women 21 to 29 years old without a history of cervical cancer, or in utero exposure to
      DES and who are not immunocompromised repeat every 3 years.

    Women ages 30-65 without a history of CIN2+, cervical cancer, or in utero exposure to
     DES and who are not immunocompromised have two options for cervical cancer
     screening. One recommendation for screening is cytology every three years. Another
     option for women with negative prior screening who want to lengthen the screening
     interval, is screening with a combination of cytology and HPV testing every 5 years.
     “Women choosing co-testing to increase their screening interval should be aware that
     positive screening results are more likely with HPV-based strategies than with cytology
     alone and that some women may require prolonged surveillance with additional frequent
     testing if they have persistently positive HPV results. The percentage of U.S. women
     undergoing co-testing who will have a normal cytology test result and a positive HPV test
     result (and who therefore require additional testing) ranges from 11% among women age
     30 to 34 years to 2.6% among women age 60 to 65 years.” …USPSTF

   SATISFACTORY/ NEGATIVE FOR INTRAEPITHELIAL LESION WITH PRESENCE
   OF ORGANISMS OR REACTIVE CELLULAR CHANGES:
      Clinician consult to decide if treatment is indicated
      Repeat Pap test at next scheduled screening

   ENDOMETRIAL OR GLANDULAR CELLS PRESENT ON A NEGATIVE PAP:
      Consult with contracted provider to determine if appointment is needed and for
       follow- up recommendation.

#2 ATYPICAL SQUAMOUS CELLS OF UNDETERMINED SIGNIFICANCE (ASC-US)
      Per ASCCP guidelines, the standard of care is that the woman can be referred for repeat
         Pap in 6 and 12 months or referral for immediate colposcopy. Contact the contracted
         provider to discuss the plan of care for follow-up. Document the provider’s order on the
         CH3-A.
      ACS-US or greater result on either 6 or 12 month repeat Pap requires colposcopic
         evaluation.
      If both tests are negative, return to routine screening.
      Please note that another standard of care, per ASCCP, is high-risk HPV DNA testing.
         The HPV DNA testing CPT code, 87621, is a reimbursable procedure if used in the
         following cases for women 30 and over: 1a) Follow-up of an ASC-US result from the
         screening exam; 1b) Surveillance at one year following an LSIL Pap test and no CIN 2, 3
         on colposcopy-directed biopsy.
 If testing for High Risk HPV DNA in patients age 30 and over is done:
                o If negative, repeat Pap test yearly until 3 documented annual normal Pap tests
                    then every 3 years (See screening algorithm)
                o If positive, then refer for colposcopy.

              o  In patients 21 to 29 years old, HPV DNA testing can be used only for triage of
                an ASCUS Pap patient to determine if colposcopy is needed. The KWCSP
                does not reimburse for HPV DNA testing in this age group.
              o If positive, then refer for colposcopy.
              o If negative, repeat Pap test in 12 months.

                                               Page 16 of 27
                                        Core Clinical Service Guide
                                   Section: Cancer Screening / Follow-up
                                             September 1, 2012
              o Patients with ASCUS Pap results in this age group (21-29 years old) can also
                  be managed by repeat cytology (Pap test) at 6 months and 12 months without
                  HPV DNA testing.
       For patients under 21 who were screened prior to the 2009 ACOG screening
        guideline changes, no follow-up required and patient should return for annual Pap
        screening until age 21.

#3 ATYPICAL SQUAMOUS CELLS CANNOT RULE OUT HIGH GRADE (ASC-H)
    Refer for colposcopy evaluation and biopsy when indicated.
    For patients under 21 who were screened prior to the 2009 ACOG screening
     guideline changes, refer patient to your contracted provider for ASC-H Pap results.

#4 LOW GRADE INTRAEPITHELIAL NEOPLASIA (CIN I, Mild dysplasia, HPV)
   (LSIL)
    Refer for colposcopy evaluation
    For patients under 21 who were screened prior to the 2009 ACOG screening
      guideline changes, no follow-up required and patient should return for annual Pap
      screening until age 21.
#5 HIGH GRADE INTRAEPITHELIAL NEOPLASIA (CIN II, CIN III, Moderate-Severe
   dysplasia, or carcinoma-in-situ) (HSIL)
    Refer for colposcopy evaluation or LEEP.
    The contracted provider shall perform a review of the cytology, colposcopy, and
      histology results when no lesion or only biopsy-confirmed CIN 1 is identified after
      colposcopy in women with HSIL Pap test reports. If the review yields a revised
      interpretation, management should follow guidelines for the revised interpretation; if a
      cytological interpretation of HSIL is upheld or if review is not possible, a diagnostic
      excisional procedure (e.g., LEEP) is preferred in nonpregnant patients.
    For patients under 21 who were screened prior to 2009 ACOG screening guideline
      changes, refer patient to your contracted provider for HSIL Pap results.

#6 SQUAMOUS CELL CARCINOMA
    Refer to a qualified provider

#7 ADENOCARCINOMA OR ADENOCARCINOMA-IN-SITU
    Refer to a qualified provider

#8 UNSATISFACTORY
    Repeat Pap between 8–16 weeks (2–4 months)

#9 ATYPICAL GLANDULAR CELLS OF UNDETERMINED SIGNIFICANCE (AGC)
    Atypical Endometrial Cells: Refer for colposcopy with ECC. Endometrial biopsy is also
      indicated. Consider HPV DNA testing for a Pap result of Atypical Glandular Cells; however
      KWCSP does not reimburse for HPV DNA testing for Atypical Glandular Cells on a Pap
      result.
    All Subcategories (except atypical endometrial cells): Refer to contracted providers for
      colposcopy with ECC, HPV testing and endometrial sampling if age 35 and older or at risk
      for endometrial neoplasia (includes abnormal vaginal bleeding or conditions suggesting
      chronic anovulation).
    HPV DNA testing will be reimbursed for all subcategories of AGC except Atypical
      Endometrial Cells if age 35 and older or at risk for endometrial neoplasia.

The 2006 Consensus Guidelines for cervical follow-up are on the American Society for Colposcopy and Cervical
Pathology website at http://www.asccp.org/.

                                                    Page 17 of 27
                                             Core Clinical Service Guide
                                        Section: Cancer Screening / Follow-up
                                                  September 1, 2012
                 FOLLOW-UP PAP TESTS
      AFTER COLPOSCOPY EVALUATION OR TREATMENT
      Information in this section is guidance. All patients who have had a colposcopy or treatment must have an
         order for her next step in follow-up, treatment or future screening from the contracted provider who
                                                 performed her services.


A. POST COLPOSCOPY PLAN: OBSERVATION FOR NEG, ASCUS, OR LSIL BIOPSY

  1. Following a patient with Pap tests only (that has had confirmation of LSIL with cervical
     biopsy) has become an acceptable standard of care. To avoid unnecessary procedures
     (and their possible adverse effects) clinicians following standardized guidelines are now
     choosing not to treat these patients with Cryotherapy, Laser, or LEEP. Observational
     management is acceptable unless the lesion extends into the endocervical canal, the Pap
     test remains ASC-US or progresses to a higher-grade lesion or the lesion does not
     spontaneously resolve after 18–24 months.
  2. For women being followed with observation for LSIL (confirmed with the diagnostic
     colposcopy and biopsy) a Pap test shall be repeated at 6 - 12 months. If repeat Pap is
     ASCUS or greater, refer for colposcopy. Or, HPV DNA testing may be peformed at 12
     months. If HPV DNA testing is negative, return to routine screening. If HPV testing is
     positive refer for colposcopy. KWCSP does not reimburse for HPV DNA testing for a
     LSIL Pap result except for at one year surveillance.
  3. Observation only is not the standard of care for women with biopsy confirmed high-grade
     lesions.
  4. Follow-up colposcopy will not be paid for by the KWCSP outside of these protocols.
     However, if the colposcopist prefers to follow the patient with additional colposcopy
     examinations and/or perform their own Pap tests it will be considered for reimbursement
     by the KWCSP on an individual basis. There may be an occasion when a physician may
     choose to perform a LEEP on a patient with a negative colposcopy biopsy or when no
     biopsy was performed during the colposcopy. Reimbursement for a LEEP in these
     circumstances may be approved on a case-by-case basis. Information necessary for
     consideration of reimbursement shall be obtained from the provider by the NCM prior to
     contacting the Clinical Coordinator for consideration of payment for these services. The
     health department will be responsible for obtaining copies of the Pap tests performed
     outside of the clinic.


B. POST COLPOSCOPY PLAN: FOLLOWING TREATMENT

  1. If the patient has had Cryotherapy, Laser, LEEP, a Cold Knife Conization (CKC) or
     hysterectomy (with removal of cervix and uterus) for treatment of CIN 2 or CIN 3 or
     cervical cancer, a Pap test will be repeated at the health department every 6 months for 1
     year after treatment Pap should be repeated annually for 20 years after treatment. (If
     abnormal result, refer to Management of Abnormal Pap Test Results)
  2. If the provider and patient make a decision to have the Pap tests performed at the
     physician’s office this will be considered for reimbursement by the KWCSP on an
     individual basis.
  3. The health department will be responsible for obtaining Pap results from the provider.


                                                  Page 18 of 27
                                           Core Clinical Service Guide
                                      Section: Cancer Screening / Follow-up
                                                September 1, 2012
          DIAGNOSTIC SERVICES & APPROVED CPT CODES
The Kentucky Women’s Cancer Screening Program covers most but not all diagnostic services
on income eligible women for the screening test results listed below. Sometimes, a screening or
diagnostic test result will have multiple diagnoses or results. When reading a test result, the
NCM must always use the more severe diagnosis for planning diagnostic referrals or
determining eligibility for the BCCTP. As a federally funded program, KWCSP is forbidden to
use program funds to pay for diagnostic services on women with Medicaid, Medicare, or private
insurance.
Mammogram Results (Screening or Diagnostic)
The corresponding number reflects the universal BI-RADS reporting system
0 - Assessment Incomplete
3 - Probably Benign
4 - Suspicious Abnormality
5 - Highly Suggestive of Malignancy
6- Known Biopsy-Proven Malignancy

Ultrasound Results
0-Needs additional imaging evaluation
3-Probably Benign Finding
4- Suspicious Abnormality
5-Highly Suggestive of Malignancy
6- Known Biopsy-Proven Malignancy

Abnormal Clinical Breast Examination
Includes discrete masses or abnormal nipple discharge but excludes normal nodularity and/or
fibrocystic changes

Pap Test Results
The corresponding number reflects reporting used in PSRS
#2     ASC-US x2 consecutive
#3:    ASC-H
#4:    Low Grade Squamous Intraepithelial Lesion-LSIL
#5:    High Grade Squamous Intraepithelial Lesion – HSIL
#6:    Squamous Cell Carcinoma
#7:    Adenocarcinoma or Adenocarcinoma-In-Situ
#9:    AGC (Atypical Glandular Cells of Undetermined Significance)
The following page is a list of the screening and diagnostic procedures covered by the KWCSP.
They are listed by CPT code in numerical order. These procedures must be provided for all
women enrolled in the program who meet eligibility requirements either on-site (if applicable) or
with a contracted provider. To make best use of limited resources, it is necessary that all cancer
screening and preventive visits as well as Pap tests following diagnostics/treatments be
performed at the local health department. The following list does not include reimbursement
rates and is not intended to replace the “Kentucky Women’s Cancer Screening Program
Approved CPT Codes and Reimbursement Rates for Breast and Cervical Cancer Screening
Follow-up.”


                                               Page 19 of 27
                                        Core Clinical Service Guide
                                   Section: Cancer Screening / Follow-up
                                             September 1, 2012
                   REQUIRED DIAGNOSTIC PROCEDURES
              AS INDICATED BY THE ABNORMAL TEST RESULT
                            (May be provided either on site or off site as appropriate)

                                   Kentucky Women's Cancer Screening Project
                                                      Approved CPT Codes
                                  Breast and Cervical Cancer Screening and Follow-up
                                                                                             Cost Center-
CPT Code                                          Service Description                       Minor Obj
00400     anesthesiology, breast follow up (base rate per unit cost)                        813-205
00940 *   anesthesiology, cervical follow up (base rate per unit cost)                      813-205
10021      fine needle aspiration without image                                              813-304
10022      fine needle aspiration with image                                                 813-304
19000      cyst aspiration (puncture)                                                        813-304
19001      cyst aspiration, additional                                                       813-304
19030 *    injection procedure only for ductogram or galactogram                             813-304
19100      breast biopsy, needle core – no imaging guidance                                  813-304
19101      breast biopsy, incisional, open                                                   813-304
19102      percutaneous, needle core, using imaging guidance                                 813-304
19103      percutaneous, automated vacuum assisted                                           813-304
19120      excision of breast tissue                                                         813-304
19125      excision of tissue identified preoperatively                                      813-304
19126      excision of tissue identified preoperatively, additional                          813-304
19290      preoperative placement of needle wire                                             813-304
19291      preoperative placement of needle wire, additional                                 813-304
19295      image guided placement                                                            813-304
57452      colposcopy of cervix, upper/adjacent vagina                                       700-305
57454      colposcopy with biopsy of cervix & endocervical curettage                         700-305
57455      colposcopy with biopsy of the cervix                                              700-305
57456      colposcopy with endocervical curettage                                            700-305
57460      colposcopy with loop electrode excision of cervix                                 700-305
57461      colposcopy with loop electrode conization of cervix                               813-305
57500      biopsy or excision of lesion, with or without fulguration                         813-305
57505      endocervical curettage                                                            813-305
57510 *    cauterization of cervix                                                           813-305
57511 *    Cryocautery                                                                       700-305
57513 *    laser ablation                                                                    813-305
57520      conization of cervix                                                              813-305
57522      loop electrode excision                                                           813-305
58100      endometrial biopsy (only when linked with AGUS result)                            700-305
58110 *e   endometrial biopsy performed in conjunction with colposcopy                       700-305
S0613 *    Clinical Breast Exam                                                              700-110
77052 *    CAD for use with screening mammogram (use in conjunction with 77057 or G0202)   813-304/308
77053 *    Ductogram                                                                         813-304
77054 *    ductogram, multiple ducts                                                         813-304
77055      diagnostic mammogram, unilateral                                                813-304/308
77056      diagnostic mammogram, bilateral                                                 813-304/308
77057      screening mammogram                                                               813-308
G0202 d    digital mammography                                                               813-308

                                                              Page 20 of 27
                                                       Core Clinical Service Guide
                                                  Section: Cancer Screening / Follow-up
                                                            September 1, 2012
                                      Kentucky Women's Cancer Screening Project
                                                          Approved CPT Codes
                                    Breast and Cervical Cancer Screening and Follow-up
                                                                                                                Cost Center-
CPT Code                                               Service Description                                     Minor Obj
G0204 d         diagnostic digital mammography, bilateral                                                     813-304/308
G0206 d         diagnostic digital mammography, unilateral                                                    813-304/308
77031           stereotactic localization for breast biopsy                                                     813-304
77032           preoperative placement of needle wire, interpretation                                           813-304
76098           radiologic examination, breast surgical specimen                                                813-304
76645           ultrasound (breast echography)                                                                  813-309

76937 *
                ultrasonic guidance for cyst aspiration                                                        813-304
76942           ultrasonic guidance for needle biopsy (use in conjunction with 19000 or 19001)                  813-304
87621 a         papillomavirus, human, amplified probe technique (Hybrid Capture II from Digene-HPV Test)       718-305
88104 *b        cytopathology, fluids, washings or brushings (breast)                                           718-304
88141           pap smear, requiring interpretation by physician (abnormals only)                               718-305
88142           pap smear, thin layer preparation, manual screening                                             718-305
88143 *         pap smear, thin layer preparation, manual screening and rescreening                             718-305
88164           pap smear, technical component                                                                  718-250
88172           evaluation of fine needle aspiration                                                            813-304
88173           interpretation and report of fine needle aspiration                                             813-304
88174 *         pap smear, thin layer preparation, automated                                                    718-305
88175           pap smear, thin layer preparation, automated & manual                                           718-305
88305           surgical pathology, gross and microscopic examination                                         813-304/305
88307           surgical pathology, associated with LEEP or breast excision requiring evaluation of margins     813-305
                pathology consultation during surgery, first tissue block, with frozen section(s), single
88331 *
                specimen
                                                                                                               813-305
88332 *         pathology consultation during surgery, each additional tissue block with frozen section(s)     813-305
99201 c         initial-brief evaluation/management                                                            700-201
99202 c         initial-expanded evaluation/management                                                         700-201
99203 c         initial-detailed evaluation/management                                                         700-201
99204 *c        initial-comprehensive evaluation/management                                                    700-201
            c
99205 *         complex-evaluation/management                                                                  700-201
99211 c         subsequent-brief evaluation/management                                                         700-201
99212 c         subsequent-limited evaluation/management                                                       700-201
99213 c         subsequent-expanded evaluation/management                                                      700-201
            c
99214 *         subsequent-detailed evaluation/management                                                      700-201
99215 *c        subsequent-comprehensive evaluation/management                                                 700-201
99385 *c        initial preventative medicine evaluation 21 - 39 yrs                                           700-201
        c
99386           initial preventative medicine evaluation 40 - 64 yrs                                           700-201
99387 *c        initial preventative medicine evaluation 65 and older                                          700-201
99395 *c        periodic preventative medicine evaluation 21 - 39 yrs                                          700-201
99396 c         periodic preventative medicine evaluation 40 - 64 yrs                                          700-201
            c
99397 *         periodic preventative medicine evaluation 65 and older                                         700-201
W9201           initial-brief evaluation/management                                                              700
W9202           initial-expanded evaluation/management                                                           700
W9203           initial-detailed evaluation/management                                                           700
W9204 *         initial-comprehensive evaluation/management                                                      700
W9205 *         complex-evaluation/management                                                                    700
W9211           subsequent-brief evaluation/management                                                           700

                                                                   Page 21 of 27
                                                            Core Clinical Service Guide
                                                       Section: Cancer Screening / Follow-up
                                                                 September 1, 2012
                                   Kentucky Women's Cancer Screening Project
                                                       Approved CPT Codes
                                 Breast and Cervical Cancer Screening and Follow-up
                                                                                                                       Cost Center-
CPT Code                                           Service Description                                                Minor Obj
W9212        subsequent-limited evaluation/management                                                                     700
W9213        subsequent-expanded evaluation/management                                                                    700
W9214 *      subsequent-detailed evaluation/management                                                                    700
W9215 *      subsequent-comprehensive evaluation/management                                                               700
W9385 *      initial preventative medicine evaluation 21 - 39 yrs                                                         700
W9386        initial preventative medicine evaluation 40 – 64 yrs                                                         700
W9387 *      initial preventative medicine evaluation 65 and older                                                        700
W9395 *      periodic preventative medicine evaluation 21 - 39 yrs                                                        700
W9396        periodic preventative medicine evaluation 40 - 64 yrs                                                        700
W9397 *      periodic preventative medicine evaluation 65 and older                                                       700
W0166 *      charge for use of hospital room (outpatient)                                                                 813-311
 Maximum 4 units up to 1 hour
* Covered by State Funds only
a The HPV DNA testing CPT code, 87621, is a reimbursable procedure if used in the following cases for women 30 years and older: 1a)
Follow-up of an ASC-US result from the screening exam; 1b) Surveillance at one year following an LSIL Pap test and no CIN 2, 3 on
colposcopy-directed biopsy; and 2) In the initial workup of women 35 years and older or at risk for endometrial neoplasia with
ATYPLICAL GLANDULAR CELLS OF UNDETERMINED SIGNIFICANCE (AGC) (except atypical endometrial cells), a colposcopy, HPV
DNA Test and Endometrial Sampling shall be performed.
b Effective October 1, 2001, this pathology code is not to be used on routine breast cysts (clear fluid/disappears on ultrasound). Only to
be used for cases with bloody/abnormal fluid or cysts that does not disappear on ultrasound.
c When this evaluation/management or preventative service is performed in-house by a Registered Nurse, code W920- should be billed
instead of 9920- for a new patient and code W921- instead of 9921- for established patients.
d Digital mammography is approved at the conventional film rate per CDC 10/6/05.
e Use code 58110 in conjunction with 57452, 57454-57456, and 57460-57461. List code separately in addition to code for primary
procedure.




                                                               Page 22 of 27
                                                        Core Clinical Service Guide
                                                   Section: Cancer Screening / Follow-up
                                                             September 1, 2012
                    TRACKING AND FOLLOW-UP REQUIREMENTS

The Local Health Department (LHD) is accountable for tracking patients with abnormal screening test results
regardless of the patient’s age, income or insurance status, to ensure that all women receive the necessary re-
screening or diagnostic follow-up services to reach a timely final diagnosis and begin treatment. This includes
those patients where the screening occurred in another program such as family planning, pediatrics, or prenatal.

Each clinic site is responsible for assigning this tracking responsibility to a Registered Nurse, Advanced
Registered Nurse Practitioner or Licensed Practical Nurse. The nurse that assumes this responsibility is referred
to as the Nurse Case Manager (NCM).

Prior to assuming the role and responsibilities of NCM with the KWCSP, the nurse must complete the following
educational modules on TRAIN; How to Best Utilize the State’s Breast and Cervical Cancer Screening and
Treatment Programs (Course # 1009091), Cancer Screening and Follow-Up Using the Public Health
Practice Reference (Course # 1013695), Kentucky Public Health Nurse Case Management: Helping Women
with Abnormal Breast and Cervical Cancer Screening Results (Course # 1013696) and Documentation:
Kentucky Public Health Nurse Case Management for Abnormal Breast and Cervical Cancer Screening
Follow-up (Course # 1020005). These modules are optional for the backup NCM who assumes this role
during an absence of the assigned NCM as described below.

The following modules are highly recommended; Who are the Never and Rarely Screened? Kentucky
Women Share Insights about the Impact of their Care and How You Can Make the Difference (Part 1
Course # 1010683, Part 2 Course # 1010684).

When there is a staff change for the NCM position, the Nursing or Clinical Supervisor must notify the Clinical
Coordinator of the KWCSP at 502-564-3236, as soon as possible. Face-to-face training will be provided to
each new NCM by the Clinical Case Management Coordinators assigned to each county.

There must also be another RN, LPN or ARNP trained by the Clinical Coordinator or Case Management
Coordinator assigned to your county and knowledgeable about cancer screening follow-up available to assume
the Nurse Case Manager’s (NCM) role and responsibilities in the event the NCM is absent for more than seven
calendar days. A timely diagnosis is crucial to creating positive outcomes in cancer screening.

Tracking and follow-up can be time consuming and therefore it is recommended that professional and support
staff work as a team toward this effort. The NCM is required to provide patient contact, counseling, tracking,
and follow-up while the support staff may assist the case manager by scheduling appointments, obtaining
records, and electronic entry of data. The NCM shall review all patient appointment arrangements and medical
records to provide detailed documentation in the Progress Notes of the patient’s medical chart. Administrative
time is imperative for NCMs to meet program requirements. The NCM should assure that all aspects of the
case management process are appropriately documented in the patient’s service record.

The NCM must have an organized manual or electronic tracking system in place to assure that patients receive
appropriate and timely intervention. It is also strongly recommended that the ACH-58 Case Management Form
side (in this section) be used to assist staff with this required tracking and follow-up. (See Administrative
Reference for instructions on Data Collection side of form.)
It is the responsibility of the KWCSP Nurse Case Manager (NCM) to contact the patient, surgeon or oncologist
to ensure the patient has begun treatment for a cancer or pre-cancerous condition. The patient must have had a
service that either removed part or all of her cancer or received chemotherapy or radiation to reduce her cancer
                                                       Page 23 of 27
                                                Core Clinical Service Guide
                                           Section: Cancer Screening / Follow-up
                                                     September 1, 2012
for her treatment to be considered started. The NCM does not continue to provide case management for
treatment once a patient is on the treatment program (BCCTP). The patient’s care will be managed by her
Kentucky Medicaid health care providers. The NCM does not need to request treatment records. However, the
NCM must document on the CH-3 nursing notes, the type of treatment that began the patient’s care and the date
that it was performed. The NCM shall document the source of this information (doctor’s name and specialty,
patient, etc.).
For further testing and management after the initial abnormal result, patients who qualify for KWCSP should be
case managed by the local health department according to program guidelines. However, when a patient has a
medical home, the patient may be referred back to the primary care physician for follow-up management, after
the patient is informed of the abnormal test and need for follow-up. Health departments should have good
communication with local medical home providers so that each provider’s role and expectations are clear.

A flowchart outlining the case management guidelines can be found at the end of this case management section.

A.     Informing the Patient of Abnormal Results

Patients with an abnormal Pap test or mammogram result must be notified within 10 working days from receipt
of the abnormal test result or within 30 days from the test date (which ever comes first) following this plan of
action:

    1. Whenever possible, the NCM shall contact the patient by telephone and have her come to the clinic for
       face-to-face counseling for abnormal test results. It is expected that the clinic has emergency numbers
       for all “no home contact” patients. Guidance for “no home contact” patients and minors is found in
       KRS 214.185.
    2. When the patient comes in to the Health Department for counseling, test results and recommendations
       for follow-up are reviewed with the patient, options discussedand a letter explaining the result in writing
       is given to the patient. Arrangements for follow-up are then made (see Section B). The visit shall be
       documented in the patient chart.
    3. If the NCM is unable to make verbal contact with the patient by phone then an attempt to contact the
       patient by letter on the same day as the unsuccessful phone call is necessary. The letter shall inform the
       patient about the abnormal test result with instructions to contact the NCM at the health department.
    4. If the patient does not respond within 10 working days after the letter is mailed, the nurse shall then send
       a certified letter to the patient informing her of her abnormal test results with instructions to contact the
       health department.
Once the above has been completed with no response then it is appropriate to document the patient as lost to
follow-up.

B.     Follow-up for Abnormal Test Results

All patients with abnormal lab tests need follow-up. Patients who meet eligibility criteria for KWCSP must be
referred according to program guidelines to contracted specialists for further testing/evaluation. Other patients
may have a medical home (regular source of medical care) outside of the local health department (LHD). The
patient’s medical home/PCP can be determined at registration.

Medical homes may include private physicians, Passport providers, Primary Care Centers, FQHC’s, and
Community Health Centers. These providers generally arrange and provide follow-up care for their patients.
Each local health department should maintain open communication with primary care providers in their area to
be sure there is agreement on roles and expectations for follow-up of patients with abnormal results.

                                                        Page 24 of 27
                                                 Core Clinical Service Guide
                                            Section: Cancer Screening / Follow-up
                                                      September 1, 2012
B1. Follow-up Arrangements for KWSCP-eligible Patients

1. The NCM will schedule an appointment for the patient with a KWCSP contracted provider for the
   appropriate follow-up testing or evaluation. A referral letter and reports of the abnormal test results are
   sent to the contracted provider who will be seeing the patient.
2. The NCM tracks to see that the patient showed for the appointment and documents the visit in the
   patient’s chart.
3. The NCM collects reports from the contracted provider and makes arrangements for further diagnostic
   testing as ordered.
4. If the patient does not keep an appointment for a scheduled consult appointment, diagnostic procedure,
   treatment, or follow-up/repeat Pap, a certified letter will be sent to the patient within 10 working days of
   the missed appointment. No further follow up tracking is needed for these patients.
5. All attempts of patient contact shall be documented in the progress notes (CH3A).
6. If the patient is a minor with a potentially life-threatening test result (includes a “HSIL” or “ASC-H”
   result on a Pap test or a “Suspicious Abnormality” or “Highly Suggestive of Malignancy” mammogram
   or ultrasound result) and cannot be contacted, the parent or guardian must be contacted. Minors shall be
   made aware of this policy at the screening visit.


B2. Follow-up Arrangements for Patients with a Medical Home

1. The NCM will schedule an appointment for the patient with their PCP for the appropriate follow-up
   testing or evaluation. A referral letter and reports of the abnormal test results are sent to the Primary
   Care provider who will be seeing the patient. Document in the progress notes (CH3A) all transfer of
   care actions provided for the patient.
   NOTE: It is imperative that the PCP is informed of any of their patient’s abnormal test results. This
   will allow the PCP to assure that the patient receives the appropriate follow-up care.
2. If the patient is a minor with a potentially life-threatening test result (includes a “HSIL” or “ASC-H”
   result on a Pap test or a “Suspicious Abnormality” or “Highly Suggestive of Malignancy” mammogram
   or ultrasound result) and cannot be contacted, the parent or guardian must be contacted. Minors shall be
   made aware of this policy at the screening visit.

B3. Follow-Up Arrangements for Patients with a Medical Home Under Passport

 1. The NCM will schedule an appointment for the patient with their PCP for the appropriate follow-up
     testing or evaluation. A referral letter and reports of the abnormal test result(s) are to be sent to the PCP
     who will be seeing the patient. Document in the progress notes (CH3A) all transfer of care actions
     provided for the patient.
     NOTE: It is imperative that the PCP is informed of any of their patient’s abnormal test results. This will
     allow the PCP to assure that the patient receives the appropriate follow-up care.
2. If the patient is a minor with a potentially life-threatening test result (includes a “HSIL” or “ASC-H”
    result on a Pap test or a “Suspicious Abnormality” or “Highly Suggestive of Malignancy” mammogram
    or ultrasound result) and cannot be contacted, the parent or guardian must be contacted. Minors shall be
    made aware of this policy at the screening visit.
3. All attempts of contact with the patient and PCP shall be documented in the patient’s progress notes
    (CH3A).




                                                     Page 25 of 27
                                              Core Clinical Service Guide
                                         Section: Cancer Screening / Follow-up
                                                   September 1, 2012
C.      Other Situations:

     Patients who are not KWCSP eligible and do not have a medical home: Local Health Departments may
     screen some patients who are not eligible for KWCSP and do not have a medical home. Efforts should be
     made to find the patient a medical home. If that is not possible, then the LHD may manage these patients
     following KWCSP protocols and providers. Efforts should be made to find other resources for financial
     assistance in these circumstances as they would not be covered by the KWCSP.

     Work-up Refused: occurs when a patient has been notified and counseled (by phone or in person) regarding
     an abnormal result and either fails to keep a referral appointment for diagnostics/treatment or verbalizes her
     desire not to seek follow-up. The date of final contact should be noted in the service record (CH3A) and on
     ACH-58 Data Collection Form side (women 40–64 years old).

     Lost to Follow-up: occurs when unable to inform and counsel the patient, either by phone or in person,
     regarding an abnormal test result. The date of the final contact attempt should be noted in the service record
     (CH3A) and on ACH-58 Data Collection Form side (women 40–64 years old).




                                                        Page 26 of 27
                                                 Core Clinical Service Guide
                                            Section: Cancer Screening / Follow-up
                                                      September 1, 2012
           Able to contact pt by phone within 10 working days of receipt of abnormal test result or 30 days from procedure.




     YES

                                                                                                                                         NO

       Schedule
      counseling
     appointment.                                                                                                Send letter to pt. w/ regarding
                                                                                                                  abnormal results & need to
                                                                                                                         contact LHD.

                                                            Send certified letter within 10
       Pt. shows for                                       working days of missed appt. &
      counseling appt.             NO                          document pt. refused.                              Did pt. contact LHD within 10
                                                                                                                  working days of letter being
                                                                                                                  mailed?
  Counsel, give letter w/ result & schedule follow-
  up. Refer to LHD/Dx contracted provider or PCP.
                                                                                               YES-Schedule counseling              NO-Send certified
                                                                                              appointment. See left side of           letter to pt.
   Send copy of results to LHD           Send copy of                                                  diagram
      contracted provider.               results to PCP.

                                                                                                                Response from pt. within 10 working
  Did patient keep                 Yes-PCP                                                                            days of certified letter.
  appointment?                     follows pt.

                                                                                                               NO-Document             YES-Schedule
  YES               NO                                                                                        lost to follow-up         appointment.
                                                                                                                                       See left side of
                                                                                                                                          diagram.
  Assure that results are obtained &
  documented. Evaluate results for further need
  of diagnostic services.



  Does pt. require further diagnostics per
  report?




                                         NO-Contact pt. &
       YES-Notify pt. &                  counsel regarding
     coordinate further dx               further screening
         procedures.                     recommendation.




  Did pt. keep secondary dx follow-up
      appointments for services?                           NO




YES-Assure that results are obtained & documented.
Contact pt. by phone within 10 working days of
receipt or 30 days from procedure date to discuss
further screening/dx results.




                     Could patient be reached by
                               phone?




    YES-Assure that pt.                                    NO
    understands further
        screening
    recommendations.
                                                                        Page 27 of 27
                                                                 Core Clinical Service Guide                                                              –
                                                            Section: Cancer Screening / Follow-up
                                                                      September 1, 2012

				
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